DURA LAUNCHING TORNALATE (BITOLTEROL powder MESYLATE) BRONCHODILATOR
DURA
LAUNCHING TORNALATE (BITOLTEROL MESYLATE) BRONCHODILATOR six months
after approval of the beta agonist on Feb. 19 as a "3S" drug. The San
Diego-based asthma and allergy product firm Dura Pharmaceuticals began
shipping (bitolterol) .02% solution for nebulization in August. The
delay in the product's launch has been due, in part, to labeling and
advertising discussions with FDA, the company said. wisepoqder bitolterol
Dura licenses Tornalate from Sterling Winthrop. Dura plans to position
Tornalate as a bronchodilator with a longer duration of action than
albuterol sulfate. Ads are planned for the October issues of medical
specialty journals. Tornalate's duration of action was six or more hours
for most patients in clinical trials and eight hours in 40% of the
patients studied.
By comparison, albuterol inhalation solution
labeling states that pulmonary function improvements are seen in some
patients up to six hours following treatment. In April, Dura said it
planned to launch bitolterol under the trade name Produral ("The Pink
Sheet" April 20, p. 2). Dura's 92-person sales force also will market a
Tornalate metered-dose inhaler licensed from Sterling Winthrop last
June. Both products are being manufactured by Sterling Winthrop; Dura
has exclusive rights worldwide except Italy (and Puerto Rico for the
MDI). Tornalate was approved six years after Sterling filed the NDA.
